Back to resultsIntravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lucentis alone group
Lucentis dexamethasone group
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography [OCT]).
- Best corrected visual acuity of 6/12 or less.
Exclusion Criteria:
● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
- History of panretinal photocoagulation within the last 6 months.
- PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
- Macular ischemia, as indicated with Fluorescein Angiography.
- Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
- Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
- Vitreomacular traction syndrome.
- Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
- Glaucoma, whether suspected or confirmed.
- Significant media opacity.
- Patients with ocular or periocular infections, or infection in the other eye
- Signs of Active or resolved uveitis and intraocular inflammation.
- Bad diabetic control as indicated by HbA1C >8.
- Renal impairment, hepatic impairment, or congestive heart failure.
- History of cardiovascular insult or stroke.
Sites / Locations
- Khaled G Abueleinen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
The first group, Lucentis alone group
The second group, Lucentis dexamethasone group
Arm Description
The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle.
The second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).
Outcomes
Primary Outcome Measures
Central foveal thickness
Central foveal thickness in microns measured by OCT
BCVA (Decimal)
Best corrected visual acuity measured on Snellen chart in Decimal form
The number of injections
The total number of injections in each Arm group
Secondary Outcome Measures
IOP
Intraocular pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05271539
Brief Title
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
Official Title
Comparative Study of the Efficacy of Intravitreal Ranibizumab Versus Its Combination With Commercial Dexamethasone in The Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.
Detailed Description
This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.
Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.
Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.
Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.
. The number of injections needed to achieve the same effect on CMT and BCVA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. While the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The first group, Lucentis alone group
Arm Type
Active Comparator
Arm Description
The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle.
Arm Title
The second group, Lucentis dexamethasone group
Arm Type
Active Comparator
Arm Description
The second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).
Intervention Type
Drug
Intervention Name(s)
Lucentis alone group
Intervention Description
The Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns
Intervention Type
Drug
Intervention Name(s)
Lucentis dexamethasone group
Intervention Description
Lucentis dexamethasone group received intravitreal injections of combination of both lucentis and commercial dexamethasone. the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Treatment was stopped when CMT improved below 250 µ.
Primary Outcome Measure Information:
Title
Central foveal thickness
Description
Central foveal thickness in microns measured by OCT
Time Frame
6 months after the first injection
Title
BCVA (Decimal)
Description
Best corrected visual acuity measured on Snellen chart in Decimal form
Time Frame
6 months after the first injection
Title
The number of injections
Description
The total number of injections in each Arm group
Time Frame
over 6 months duration of the study
Secondary Outcome Measure Information:
Title
IOP
Description
Intraocular pressure
Time Frame
6 months after the first injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography [OCT]).
Best corrected visual acuity of 6/12 or less.
Exclusion Criteria:
● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
History of panretinal photocoagulation within the last 6 months.
PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
Macular ischemia, as indicated with Fluorescein Angiography.
Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
Vitreomacular traction syndrome.
Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
Glaucoma, whether suspected or confirmed.
Significant media opacity.
Patients with ocular or periocular infections, or infection in the other eye
Signs of Active or resolved uveitis and intraocular inflammation.
Bad diabetic control as indicated by HbA1C >8.
Renal impairment, hepatic impairment, or congestive heart failure.
History of cardiovascular insult or stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled G Abueleinen, MD, PhD
Organizational Affiliation
Ophthalmology department, Faculty of Medicine Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khaled G Abueleinen
City
Giza
State/Province
Cairo
ZIP/Postal Code
12411
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
29127949
Citation
Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.
Results Reference
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Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
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